Event Group
Event Groups are part of the Adverse Events Module within the Results Section. They provide a way to organize and summarize adverse event data by grouping related events together.
Each Event Group typically represents a category or class of adverse events and includes statistical information such as the number of participants affected and at risk for different event types: deaths, serious events, and other events.
Event Group path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Group
Event Group
Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2025-12-25 @ 10:03 PM
NCT ID:
NCT00138658
Group ID:
EG000
Title:
OGX-011 - Intent to Treat Analysis Set
Description:
Custirsen sodium (OGX-011) was to be infused intravenously over 2 hours on Days -7, -5, and -3 of Cycle 1 (Pretreatment loading doses). OGX-011 was then to be infused for 2 hours weekly on Days 1, 8, and 15 of a 21-day cycle. Gemcitabine (GEM) was to be infused IV for 30 minutes on Days 1 and 8 and either cisplatin (CIS) or carboplatin (CARBO) were to be infused IV on Day of the 21-day cycle. Patients were to receive a maximum of 6 cycles (1 cycle =21 days). Most patients received OGX-011 at 640 mg; but 3 patients received a 480 mg dose. The 2 dose groups were combined due to the small number of patients who received 480 mg. All patients who received at least one dose of OGX-011 were included in the Intent to Treat Analysis Set.
Deaths Number Affected:
None
Deaths Number At Risk:
None
Serious Number Affected:
32
Serious Number At Risk:
81
Other Number Affected:
81
Other Number At Risk:
81
Study:
NCT00138658
Results Section:
NCT00138658
Adverse Events Module:
NCT00138658